510(k) Report

Devices descending from K060754

1 later device reach Elecsys TSH Calset W/Models 04738551 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062581Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemOlympus America, Inc.20060—